Study Stopped
Ethical commentate has not be obtained by the institution.
Splint Versus Non-splint Implant Impressions
Prosthetic Fit Improving With Splint Implant Impressions: Double-blind, Randomised Clinical Trial of Accuracy and Materials.
1 other identifier
interventional
N/A
1 country
2
Brief Summary
The purpose of this study is to evaluate the effectiveness of heavy Vinyl PolySiloxane (VPS) and splinted implants impression (Study Group, SG) technique versus plaster implant impression (Control Group, CG) technique, in 12 edentulous patients rehabilitated with the All-on-4/6 concept and Procera® Implant Bridge (P.I.B.). A longitudinal, double blinded, randomised clinical trial (RCT) was designed to evaluate the accuracy of the impression. All patients were monitored from implant placement until prosthetic loading.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 21, 2018
August 1, 2018
3 months
April 2, 2010
August 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implant failure
An implant was consid- ered to be a failure if it was lost owing to mobility, implant fracture and/or any infection requiring implant removal.
Up to 5 years after implant placement
Secondary Outcomes (2)
Inter-implants distance between groups
4 to 5 months after implant placement (baseline)
Chair-time
4 to 5 months after implant placement (baseline)
Study Arms (2)
Snow white Plaster 2
EXPERIMENTALTest
Primopattern LC gel + PVS
ACTIVE COMPARATORControl
Interventions
Eligibility Criteria
You may qualify if:
- Age 21 years or older.
- Both genders.
- Fully edentulous patients.
- Both maxilla and mandible.
- Dental implant rehabilitation utilizing the All-on-4 concept at least 8 weeks before impression.
- External hex dental implant.
- Patients with ability to understand and sign the informed consent prior to starting the study.
- Adequate oral hygiene.
- Immediate functional loading.
- Implant stability quote value =/\> 65 from implant placement to final prosthetic rehabilitation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital San Pietro Fatebenefratellilead
- Nobel Biocarecollaborator
Study Sites (2)
Marco Tallarico
Rome, RM, 00151, Italy
Studio odntoiatrico specialistico dr. Marco Tallarico
Rome, RM, 00151, Italy
Related Publications (1)
Lee H, So JS, Hochstedler JL, Ercoli C. The accuracy of implant impressions: a systematic review. J Prosthet Dent. 2008 Oct;100(4):285-91. doi: 10.1016/S0022-3913(08)60208-5.
PMID: 18922257BACKGROUND
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Marco Tallarico, dr.
Private Practice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 2, 2010
First Posted
April 15, 2010
Study Start
June 1, 2010
Primary Completion
September 1, 2010
Study Completion
May 1, 2011
Last Updated
August 21, 2018
Record last verified: 2018-08